Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs, including ENGERIX-B, because FDA testing found microorganisms and fungal growth in the production clean room.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves sterile injectable drugs contaminated with microorganisms and fungal growth, which poses a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall includes the product ENGERIX-B, SDV 20MCG/ML INJECTABLE 1 ML. The distribution of these products was nationwide and included the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This finding indicates a lack of assurance of sterility for the affected products.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)
- Category
- Drug — Injectable
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #: 0410015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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